Randomised, placebo controlled clinical trial to evaluate remifentanil as maternal sedation and fetal immobilisation during diagnostic prenatal MRI.
Phase 1
- Conditions
- Maternal sedation and fetal immobilization during MRI
- Registration Number
- EUCTR2009-011281-28-BE
- Lead Sponsor
- niversity Hospitals Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 50
Inclusion Criteria
Gestational age between 18 and 34 weeks
no contra indication for MRI
no allergy for remifentanil
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1. Evaluation of fetal immobilization during prenatal MRI<br>2. Evaluation of maternal sedation during prenatal MRI;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method